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United States · US · US:65862-083_74923cbc-7511-447d-b6b2-b2d0e805a0f5
Cefadroxil
Orange BookUNIISPLATC J01DB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01DB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116586208301100 mL in 1 BOTTLE (65862-083-01)
- ndc11658620835050 mL in 1 BOTTLE (65862-083-50)
Annotations
UNII (FDA Substance ID)
280111G160
CEFADROXIL
RxCUI 204175
Orange Book
A065349
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "280111G160",
"rxcui": "204175",
"inchikey": "NBFNMSULHIODTC-CYJZLJNKSA-N",
"display_name": "CEFADROXIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4fb524c1-f985-2a8f-e063-6394a90aab7f": {
"match": "brand_token",
"title": "CEFADROXIL CAPSULE [REDPHARM DRUG]",
"spl_version": "1",
"published_date": "2026-04-20"
}
},
"productid": "65862-083_74923cbc-7511-447d-b6b2-b2d0e805a0f5",
"productndc": "65862-083",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "065349",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE/5ML",
"product_no": "001",
"approval_date": "Apr 25, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE/5ML",
"product_no": "002",
"approval_date": "Apr 25, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFADROXIL",
"proprietary_name": "Cefadroxil",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065349",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefadroxil",
"start_marketing_date": "20130425",
"active_numerator_strength": "250"
}Related drugs
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- GBBaxan 250mg/5ml oral suspensionBristol-Myers Squibb Pharmaceuticals Ltd
- GBBaxan 500mg capsulesBristol-Myers Squibb Pharmaceuticals Ltd
- GBBaxan 500mg capsulesWaymade Healthcare Plc
- GBBaxan 500mg/5ml oral suspensionBristol-Myers Squibb Pharmaceuticals Ltd
- CZBIODROXILSandoz GmbH, Kundl
- CZBIODROXILSandoz GmbH, Kundl
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